Clinical trial · Interventional
Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy
NCT00403000CI-TRIAL-00010177completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dutasteride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Time to disease progression
- timeFrame
- Every 12 weeks
- measure
- Toxicity
- timeFrame
- Daily while on Treatment
Secondary outcomes (2)
- measure
- Objective response (complete and partial) rate and serum prostate-specific antigen levels
- timeFrame
- Every 4 weeks
- measure
- Survival
- timeFrame
- Every 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of prostate cancer
* Asymptomatic progressive disease despite androgen-deprivation therapy
* Progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with or without antiandrogen AND after antiandrogen withdrawal
* Concurrent LHRH monotherapy (i.e., LHRH analogs, such as leuprolide acetate or goserelin) required in patients who did not undergo prior bilateral orchiectomy to assure testicular androgen suppression
* Recurrent disease, as indicated by at least 1 of the following:
* Prostate-specific antigen (PSA) at baseline ≥ 2.0 ng/mL
* Biopsy-confirmed local recurrence
* Increase in size of measurable lesions on radiographic study
* New lesion on a nuclear bone scan
* Two successive increases in serum PSA measured at least 1 week apart
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Bilirubin ≤ 2.0 mg/dL
* SGOT ≤ 4 times upper limit of normal
* Creatinine ≤ 2.0 mg/dL
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered
* At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide or nilutamide
* Patients who have previously progressed despite antiandrogen withdrawal and who have started antiandrogens without reduction of serum PSA are eligible without requiring a 28- or 42-day washout interval after antiandrogen withdrawal
* No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens
* Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies
* No other concurrent anticancer therapy
* No concurrent use of any of the following:
* Finasteride
* Other investigational 5α-reductase inhibitors
* Anabolic steroids
* Alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin)
* Drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents)
* Products containing selenium ≥ 75 mcg or vitamin E ≥ 100 IU
* Saw palmetto
* EG6761
* No concurrent radiotherapy, including palliative radiotherapy for pain controlReferences
Publications (1)
- RESULTShah SK, Trump DL, Sartor O, Tan W, Wilding GE, Mohler JL. Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy. J Urol. 2009 Feb;181(2):621-6. doi: 10.1016/j.juro.2008.10.014. Epub 2008 Dec 16. PMID 19091347